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Clinical Trial NCT06943560 for PTSD is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Emotion Regulation Selection Flexibility Training for PTSD Patients 80 Novel Treatment

Recruiting
Clinical Trial NCT06943560 is an interventional study for PTSD that is recruiting. It started on October 1, 2022 with plans to enroll 80 participants. Led by Tel Aviv University, it is expected to complete by April 1, 2026. The latest data from ClinicalTrials.gov was last updated on April 24, 2025.
Brief Summary
This clinical study will examine the efficacy of a novel intervention aimed at improving Regulatory Selection Flexibility and PTSD symptoms among adult individuals with PTSD symptoms, compared to a tight active control group.
Detailed Description
Regulatory Selection Flexibility is defined as the ability to select regulatory strategies according to differing situational demands (i.e., regulatory selection flexibility rule; distraction for high intensity vs reappraisal in low intensity). The main questions it aims to answer are: \[1\] Can PTSD individuals improve Regulatory Selection Flexibility \[2\] Does improved Regulatory Selection Flexibility associate to...Show More
Official Title

Emotion Regulation Selection Flexibility Training for PTSD Patients

Conditions
PTSD
Other Study IDs
  • Sheppes01
NCT ID Number
NCT06943560
Start Date (Actual)
2022-10-01
Last Update Posted
2025-04-24
Completion Date (Estimated)
2026-04-01
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
EMOTION REGULATION
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalRegulatory selection Flexibility Training
Emotion Regulation Selection Flexibility Training
7 online computerized regulatory selection training sessions that includes a fully computerized part, and an interactive, human operated part guided by a clinician and home assignments between intervention session to be completed on days without sessions. Psychoeducation includes information on selection of appropriate strategy according to the regulatory selection flexibility rule (i.e., distraction for high intensi...Show More
ExperimentalTight Active control Training
Emotion Regulation Active control Training
All the interventional sections are similar to the experimental group except that in the control group we omit the regulatory selection rule that defines which strategy is compatible with which emotional situation. 7 online computerized regulatory selection training sessions that includes a fully computerized part, and an interactive, human operated part guided by a clinician and home assignments between interventio...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Pre to Post improvement of emotion regulatory selection flexibility
regulatory selection flexibility is calculated by subtracting adaptive choice from the maladaptive choice specifically by subtracting the proportion of distraction selection in the low intensity stimuli (maladaptive choice) from the proportion of distraction selection in the high intensity stimuli (adaptive choice).
Measurements at Baseline and immidiately post treatment
Change from baseline of the total score of the PTSD Checklist (PCL-5)
The PCL-5, is a 20-item PTSD Checklist for DSM-5. Scores can range from 0 to 80, with higher scores reflecting more PTSD symptoms.
Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • native Hebrew speakers
  • age between 18 - 65
  • normal or corrected to normal vision
  • computer and internet access
  • fulfill screening criteria of DSM-V for PTSD

  • Complex PTSD
  • Psychotic disorders
  • substance dependence or abuse other than nicotine
  • Neurological condition
  • suicidal ideation or attempt
  • change in psychotherapy or pharmacological treatment in the past 3 months.
  • Diagnosed/suspected personality Disorder
  • Cognitive impairments
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Study Responsible Party
Gal Sheppes, Principal Investigator, Principal Investigator of Emotion Regulation Lab, Tel Aviv University
Study Central Contact
Contact: Gal Sheppes, PhD, 0528681031, [email protected]
Contact: Naomi Fine, PhD, 0528681031, [email protected]
1 Study Locations in 1 Countries
Tel Aviv University, Tel Aviv, 6997801, Israel
Gal Sheppes, PhD, Contact, [email protected]
Naomi Fine, PhD, Contact, 0528681031, [email protected]
Recruiting